Recall Z-1767-2019
Luminex Molecular Diagnostics · initiated February 22, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Codes / lots: Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.
Reason for recall
Reports have been received of lower MS2 MFI values when using the panel.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued letters via email dated 2/22/2019.
Details
- Recall number
- Z-1767-2019
- Initiated
- February 22, 2019
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Quantity
- 965 kits
- Distribution
- Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI. There was military distribution but no government distribution.
- Recalling firm
- Luminex Molecular Diagnostics, Toronto